UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effects of foot drop stimulator controlled by a tilt sensor combined with integrated volitional control electrical stimulation on gait performance in stroke patients
Title of the study (Brief title)	The effects of foot drop stimulator controlled combined with integrated volitional control electrical stimulation in stroke patients
Region	Japan

Condition
Condition	stroke
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate whether or not foot drop stimulator controlled combined with integrated volitional control electrical stimulation would improve gait performance of patients with post-stroke
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Root mean squares of trunk acceleration during walking
Key secondary outcomes	fugl-meyer assessment (the lower extremity), stroke impairment assessment set (foot-pat test), modified ashworth scale

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Foot drop stimulator controlled combined with integrated volitional control electrical stimulation in addition to usual rehabilitation program
Interventions/Control_2	Integrated volitional control electrical stimulation in addition to usual rehabilitation program
Interventions/Control_3	Usual rehabilitation program alone
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Consent to participate in the study 2) First-time stroke with a duration of less than 6 months from the onset of stroke 3) The ability to walk without support for at least 30-meters 4) The score of SIAS foot-pat test is 1 or more. 5) Capability of communicating and understanding instructions
Key exclusion criteria	1) Contraindications for electrical stimulation 2) Severe sensory deficits 3) Neurological condition unrelated to stroke hemiparesis
Target sample size	60

Research contact person
Name of lead principal investigator	Tsubasa Mitsutake
Organization	Shiroishi Kyoritsu Hospital
Division name	Department of Rehabilitation
Address	1296 Fukuta, Shiroishi-cho, Kishima-gun, Saga
TEL	0952-84-6060
Email	mitutuba1012@gmail.com

Public contact
Name of contact person	Tsubasa Mitsutake
Organization	Shiroishi Kyoritsu Hospital
Division name	Department of Rehabilitation
Address	1296 Fukuta, Shiroishi-cho, Kishima-gun, Saga
TEL	0952-84-6060
Homepage URL
Email	mitutuba1012@gmail.com

Sponsor
Institute	Shiroishi Kyoritsu Hospital
Institute
Department

Funding Source
Organization	nothing
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	白石共立病院（佐賀県）

Other administrative information
Date of disclosure of the study information	2017 Year 01 Month 04 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 04 Day
Anticipated trial start date	2017 Year 01 Month 11 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2018 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 12 Month 30 Day
Last modified on	2018 Year 07 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029327